Who is the manufacturer of 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE?

3M Healthcare filed the 510(k) submission for 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (K140250).

What is the FDA product code for 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE?

KKX. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE?

3M™ Ioban™ 2 Antimicrobial Incise Drape (K801550).

Who can help prepare an FDA 510(k) submission like 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE

K140250 · 3M Healthcare · KKX · Jul 25, 2014 · General, Plastic Surgery

Device Facts

Record ID	K140250
Device Name	3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
Applicant	3M Healthcare
Product Code	KKX · General, Plastic Surgery
Decision Date	Jul 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Intended Use

3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

Device Story

3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile, transparent, breathable adhesive film applied pre-operatively to patient skin. The film conforms to body contours, creating a sterile surface. Surgeons incise through the film and skin, maintaining a sterile barrier to the incision edge. The adhesive contains 2% w/w Chlorhexidine Gluconate (CHG), which provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound. The device is supplied on a silicone-coated release liner, which is removed prior to application. It is used in clinical surgical settings to benefit patients by reducing potential wound contamination.

Clinical Evidence

Evidence includes bench testing (barrier performance per AAMI PB70:2012, tensile/elongation, flammability per 16 CFR 1610, MVTR, and antimicrobial activity per ASTM E2315), in vivo porcine model efficacy, and clinical adhesion panels. Porcine study showed CHG drape significantly reduced microbial contamination compared to placebo (p=0.026 at T0; p=0.001 at T4). Clinical panels demonstrated adhesion performance comparable to the predicate on various skin types with no adverse events.

Technological Characteristics

Transparent, breathable fluid barrier film with acrylic pressure-sensitive adhesive containing 2% w/w Chlorhexidine Gluconate (CHG). Supplied on a silicone-coated release liner. Sterilized via Ethylene Oxide (ISO 11135). Barrier performance meets AAMI PB70:2012 Level 4. Flammability meets 16 CFR 1610 Class I.

Indications for Use

Indicated for use as an incise drape providing continuous antimicrobial activity for surgical procedures. Intended for external use only.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

3M™ Ioban™ 2 Antimicrobial Incise Drape (K801550)

Related Devices

K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) · 3M Company · May 18, 2023
K163556 — MediClear PreOp · Covalontechnologies, Inc. · Sep 14, 2017
K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II · Avery Dennison Medical , Ltd. · Oct 25, 2023
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial · Avery Dennison Belgie Bvba · Jul 30, 2021
K955872 — VOLMED OPERATION DRAPE · Medal Intl. Sales Co., LLC · Mar 12, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul. MN 55144 651 733 1110 k140250 # JUL 2 5 2014 # 510(k) SUMMARY Sponsor Information: SM Applicant Name 3M Company 3M Health Care Infection Prevention Division 3M Center 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144 Contact Person: Phone Number: Fax Number: e-mail: 651-736-6117 651-737-5320 ktotushek@mmm.com Kristin Totushek Regulatory Affairs Date Prepared: July 23, 2014 ### Device Name and Classification: | Trade Name: | 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape | |-----------------------|------------------------------------------------------| | Common or Usual Name: | Antimicrobial Incise Drape | | Classification Name: | Surgical Drape and Drape Accessories | | Product Code: | KKX per 21CFR 878.4370 | | Predicate Device: | 3M™ loban™ 2 Antimicrobial Incise Drape (K801550) | #### Description of Device: The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile adhesive film that is applied pre-operatively to skin. The film adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The CHG contained in the adhesive provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound. {1}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape consists of a transparent, conformable, breathable fluid barrier film laminated to a lightly-tinted, acrylic pressuresensitive adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG). The adhesive drape is delivered on a silicone-coated release liner that is discarded after application. In vitro testing demonstrates that 3MTM Steri-Drape™ CHG Antimicrobial Incise Drape has broad spectrum antimicrobial activity. ## Indications for Use: 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only. | Catalog # | Color | Size | | |-----------|------------|---------------|---------------| | 8840EZ | Light pink | 13 in x 13 in | 34 cm x 35 cm | | 8848EZ | Light pink | 22 in x 23 in | 56 cm x 60 cm | | 8850EZ | Light pink | 22 in x 17 in | 56 cm x 45 cm | | 8851EZ | Light pink | 22 in x 33 in | 56 cm x 85 cm | ### Substantial Equivalence: 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is substantially equivalent to the predicate device, 3M™ Ioban™ 2 Antimicrobial Incise Drape cleared under K801550. 3MTM Steri-Drape™ CHG Antimicrobial Incise Drape is composed of the same or similar components and has the same or similar performance, intended use and indications for use as the predicate device. Based on the similarities to the predicate device, the minor differences do not present any new safety or effectiveness issues and the device is substantially equivalent to the predicate. # Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device: | Characteristic | 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape | 3M™ Ioban™ 2 Antimicrobial Incise Drape | Comparison | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | 3M™ Steri-Drape™ CHG Antimicrobial | 3M™ Ioban™ 2 Antimicrobial Incise | Same | | Characteristic | 3MTM Steri-DrapeTM CHG Antimicrobial Incise Drape | 3MTM IobanTM 2 Antimicrobial Incise Drape | Comparison | | | Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity. It is intended for external use only. | Drape is indicated for use as an incise drape with continuous antimicrobial activity. It is intended for external use only. | | | Design/Materials | Antimicrobial impregnated adhesive coated on breathable film with silicone- coated release liner. | Antimicrobial impregnated adhesive coated on breathable film with silicone- coated release liner. | Same | | Antimicrobial | Chlorhexidine Gluconate (CHG) | Iodine | Both are well characterized, broad spectrum, antimicrobials. Safety and efficacy testing demonstrates substantial equivalence. | | Sold Sterile | Yes | Yes | Same | | Sterilization Method | Ethylene Oxide sterilized, 106 SAL per ISO 11135 | Gamma Sterilized, 106 SAL per ISO 11137 | Different sterilization method but same sterility assurance level (SAL). Iodine is not compatible with Ethylene Oxide. CHG is not compatible with gamma irradiation. Both devices are sterilized to 106 SAL per respective ISO standards. | | Packaging | Film/Tyvek Pouch | Foil Pouch | Foil laminate is used to protect Ioban from EO exposure if sterilized in a kit. Film/Tyvek is used to enable sterilization of CHG drape with EO. | | Sterility Assurance Level | SAL 10-6 | SAL 10-6 | Same | | Characteristic | 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape | 3M™ Ioban™ 2 Antimicrobial Incise Drape | Comparison | | Principals of Operation | The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile adhesive film that is applied pre- operatively to skin. The film adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The CHG contained in the adhesive provides additional antimicrobial activity to reduce the risk of microbial contamination of the surgical wound. | The 3M™ Ioban™ 2 Antimicrobial Incise Drape is a sterile adhesive film that is applied pre- operatively to skin. The film adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The iodine contained in the adhesive provides additional antimicrobial activity to reduce the risk of microbial contamination of the surgical wound. | Same | | Biocompatibility | Not cytotoxic, slight irritant, not a potential skin sensitizer | Not cytotoxic, slight irritant, not a potential skin sensitizer | Same | {2}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul. MN 55144 651 733 1110 {3}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Convay, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 # Bench Testing Performance Data: Bench testing was performed to demonstrate substantial equivalence for this submission, as recommended by the FDA Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes and the additional recommendations from FDA Draft Guidance on Premarket Notification [510(k)] {4}------------------------------------------------ 3M Infection Prevention 3 M Center 2510 Conway. Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 Submissions for Medical Devices that Include Antimicrobial Agents. Data submitted includes: - Barrier performance per AAMI PB70:2012 using ASTM F1670 "Resistance to • Synthetic Blood Penetration" - . Tensile and Elongation - . Flammability testing was performed per 16 CFR 1610 - . Moisture Vapor Transmission Rate (MVTR) - in vitro Antimicrobial Activity Spectrum and Minimum Effective Concentration . (MEC) per ASTM E2315 - . CHG Release Kinetics {5}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 | Characteristic | Test Method Description | Device Component Tested | Data Summary | | Comparison | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | | | | Test Article: 3MTM Steri- Drape™ CHG Anti-microbial Incise Drape | Predicate: 3MTM Ioban™ 2 Anti- microbial Incise Drape | | | Tensile and Elongation | Based on PSTC-131, ASTM D882, ASTM D3759 | Finished Drape Incise Area, sample cut to size | Tensile > 1365 g/25mm and Elongation >500% | Tensile > 1365 g/25mm and Elongation >500% | Same | | MVTR | Based on ASTM E96 and Payne Cup Method | Finished Drape sample, cut to size | > 400 g/m²/24 hrs | > 400 g/m²/24 hrs | Same | | Flammability | 16 CFR 1610 | Finished Drape Sample | Class I (Normal) | Class I (Normal) | Same | | Barrier Performance | AAMI PB70:2012 | Finished Drape Sample, cut to size | Level 4 | Level 4 | Same | | Antimicrobial performance | ASTM E2315 | Finished Drape Sample, cut to size | Broad Spectrum, > 4 log reduction at 90 min | Broad Spectrum, >. 4 log reduction at 90 min | Same | | Characteristic | Description of Test Method | Device Component Tested | | Data Summary | Conclusion | | | | Test Article | Placebo | | | | Antimicrobial efficacy study- in vivo porcine model | Wound contamination rates of test versus placebo drape in an in vivo porcine surgical model | Finished Drape sample, cut to size. | Placebo drape sample, cut to size. | T0 $Log_{10}$ CFU/sample CHG drape lower than placebo (observed difference 0.35 $log_{10}$ , P= 0.026) T4 $Log_{10}$ CFU/sample CHG drape lower than placebo (observed difference 0.68 $log_{10}$ , P=0.001) Difference in change in $log_{10}$ counts/sample T0 to T4, observed difference 0.34 $log_{10}$ , P=0.14 $Log_{10}$ CFU/cm² under drape lower than placebo (observed difference 0.70 $log_{10}$ , P= | Test article reduces microbial contamination of surgical wound compared to the placebo | {6}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 # In vivo Animal Efficacy Data In vivo animal testing was performed to demonstrate antimicrobial efficacy compared with a placebo incise drape. {7}------------------------------------------------ 3M 1nfection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 # Clinical Performance Data: In house clinical panels were performed to demonstrate good adhesion to skin. Outside clinical adhesion studies were conducted to demonstrate safety and adhesion to various skin types. Safety data were collected in these studies to demonstrate substantial equivalence for this submission to the predicate, 3M™ loban™ 2 Antimicrobial Incise Drape. | Test | Device Component Tested | Testing Summary | Summary | Comparison | |---------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Adhesion to Skin - in house clinical panels | Finished Drape Samples, cut to size | Adhesion comparison of 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ loban™ 2 Antimicrobial Incise Drape on skin prepped with DuraPrep Solution or a leading PVP-I prep solution during a wet challenge wear study | No statistical difference in skin adhesion over either DuraPrep Solution or PVP-I prep solutions | Same performance as predicate | | Adhesion to skin - in house clinical panels | Finished Drape Samples, cut to size | Adhesion comparison of 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M loban 2 Antimicrobial Incise Drape on skin during a dry challenge wear study | Removal force of test article is higher than predicate, no difference in skin reactions | Similar performance to predicate | | Adhesion to skin - external clinical study | Finished Drape Samples, cut to size | Evaluation of skin condition and removal force post- wear on subjects with very dry and potentially fragile skin types | No adverse events associated with test article post- wear; removal force slightly higher for test article | Similar performance to predicate | {8}------------------------------------------------ 3M Infection Prevention 3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110 # Performance, Safety and Efficacy Conclusion: Based on bench, animal and clinical studies, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is as safe, as effective and is demonstrated to be substantially equivalent to the predicate device, 3M™ lobanTM 2 Antinicrobial Incise Drape. {9}------------------------------------------------ Image /page/9/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 25, 2014 3M Health Care Infection Prevention Division Ms. Kristin Totushek Regulatory Affairs Specialist 3M Center, 2510 Conway Ave. Bldg 275-5W-06 St. Paul, MN 55144 Re: K 140250 Trade/Device Name: 3MTM Steri-Drape ™ CHG Antimicrobial Incise Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: June 23, 2014 Received: June 24, 2014 Dear Ms. Totushek, We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {10}------------------------------------------------ ### Page 2 - Ms. Totushek Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Teiashri Purohit-Sheth, M.D. Clinical Deputy Director Tejashri Purohit-Sheth, M.D. DAGRID/QDE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. #### 510(k) Number (if known) K140250 #### Device Name 3MTM Steri-Drape™ CHG Antimicrobial Incise Drape Indications for Use (Describe) 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only. | Catalog # Color | Size | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-----------------------------------------------|--| | 8840EZ | | Light pink 13 in x 13 in 34 cm x 35 cm | | | 8848EZ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | Light pink 22 in x 23 in 56 cm x 60 cm | | | 8850EZ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | Light pink 22 in x 17 in 56 cm x 45 cm | | | | | 8851EZ Light pink 22 in x 33 in 56 cm x 85 cm | | Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) [x] Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, Sreekanth Guta ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.07.24 11:04:33 -04'00' PSC Publuhing Services (301) 44)-6740 Es FORM FDA 3881 (1/14) Page 1 of 2 {12}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."